Valid

YY/T 0870.7-2023Test for genotoxicity of medical devices - Part 7: In vivo mammalian alkaline comet assay (English PDF)

医疗器械遗传毒性试验第7部分：哺乳动物体内碱性彗星试验

Preview PDF

This is a limited preview

Buy now to download the full PDF (15 pages)

Need quotation for your management?

Get a formal quotation for YY/T 0870.7-2023 in 30 minutes.

Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 13, 2023

Implementation date

January 15, 2024

Scope

YY/T 0870.7-2023 is the English-translated version of 医疗器械遗传毒性试验第7部分：哺乳动物体内碱性彗星试验.

YY/T 0870.7-2023 is the Chinese standard "Test for genotoxicity of medical devices - Part 7: In vivo mammalian alkaline comet assay". Its scope clause reads: This document specifies the mammalian in vivo alkaline comet test method for genotoxicity testing of medical devices/materials.

This document is applicable to the screening of medical devices by measuring the breakage of DNA strands in the nucleus of mammalian cells caused by medical devices/materials whether the machinery/material has potential genotoxic effects.

NOTE. In vivo alkaline comet assays in mammals for nanomaterials and cross-linkers may require specific revisions to the methods in this document, but this paper The item is not described. Its clauses include terms and definitions.

Found what you need?

Document preview — YY/T 0870.7-2023

National Standard of the People's Republic of China

ICS: 11.040.01
Classification: C30

Issued by: National Medical Products Administration

1 Scope
2 Normative references
3 Terms and Definitions
7 Alkaline comet test in mammals
12 Sample preparation and reference materials

1 Scope

This document specifies the mammalian in vivo alkaline comet test method for genotoxicity testing of medical devices/materials.

NOTE. In vivo alkaline comet assays in mammals for nanomaterials and cross-linkers may require specific revisions to the methods in this document, but this paper

The item is not described.

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references

For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process

GB/T 16886.2 Biological Evaluation of Medical Devices Part 2.Animal Welfare Requirements

GB/T 16886.3 Biological Evaluation of Medical Devices Part 3.Genotoxicity, Carcinogenicity and Reproductive Toxicity Tests

GB/T 16886.12 Biological evaluation of medical devices - Part 12.Sample preparation and reference materials

3 Terms and Definitions

The following terms and definitions defined in GB/T 16886.1, GB/T 16886.3 and GB/T 16886.12 apply to this document.

3.1 comet

The tailing phenomenon of damaged DNA fragments after being subjected to an electric field.

NOTE. Under the microscopic image, the "comet" head is nuclear DNA, and the tail is composed of damaged DNA fragments that migrated out of the nucleus in the electric field.

3.2 critical variable

A test parameter for which small changes can have a large impact on test results.

NOTE. Key variables may be tissue-specific. In an experiment, changing key variables can lead to changes in the results of the experiment, for example. positive control and negative

Dosage and type of sex control.

3.3 Tail DNA

The ratio of comet tail DNA content to total DNA content (sum of head and tail DNA content).

NOTE. Tail DNA percentage reflects the relative degree of DNA damage expressed as a percentage.

3.4

"Hedgehog"-shaped cells hedgehogcels

Microscopic image of cells consisting of small or indistinct heads with large diffuse tails.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

How to Download YY/T 0870.7-2023

1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.